103140 Parteck® SI 400 (Sorbitol)

103140
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      50-70-4 200-061-5 C₆H₁₄O₆ 182.17 g/mol Ph Eur,BP,JSFA,NF,E 420

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      1031409500
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          Big Bag 500 kg
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          Description
          Catalogue Number103140
          SynonymsD-Glucitol
          References
          Product Information
          CAS number50-70-4
          EC number200-061-5
          GradePh Eur,BP,JSFA,NF,E 420
          Hill FormulaC₆H₁₄O₆
          Molar Mass182.17 g/mol
          HS Code2905 44 91
          Structure formula ImageStructure formula Image
          Applications
          Biological Information
          Physicochemical Information
          Density1.49 g/cm3 (20 °C)
          Flash point>100 °C
          Ignition temperature420 °C
          Melting Point94 - 96 °C
          pH value6 - 7 (100 g/l, H₂O, 20 °C)
          Bulk density450 kg/m3
          Solubility2350 g/l
          Dimensions
          Materials Information
          Toxicological Information
          LD 50 oralLD50 Rat 15900 mg/kg
          Safety Information according to GHS
          RTECSLZ4290000
          Storage class10 - 13 Other liquids and solids
          WGKNWG not water endangering
          Disposal3
          Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageStorage temperature: no restrictions.
          Packaging Information
          Transport Information
          Declaration (railroad and road) ADR, RIDKein Gefahrgut
          Declaration (transport by air) IATA-DGRNo Dangerous Good
          Declaration (transport by sea) IMDG-CodeNo Dangerous Good
          Supplemental Information
          Specifications
          Assay (HPLC, calc.on anhydrous substance)97.0 - 100.5 %
          Identitypasses test
          pH-value (10 %; water)3.5 - 7.0
          Free acidpasses test
          Appearance of solution (10 %; water)passes test
          Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance)+4.0 - +7.0 °
          Conductivity (25°C) (20 %; water)≤ 20
          Chloride (Cl)≤ 0.002 %
          Sulfate (SO₄)≤ 0.010 %
          Heavy metals as Pb≤ 5 ppm
          As (Arsenic)≤ 1 ppm
          Ni (Nickel) (#)≤ 1 ppm
          Pb (Lead)≤ 0.5 ppm
          Ru (Ruthenium) (#)≤ 1 ppm
          Related substances (HPLC, EP) (Major impurity (Mannitol))≤ 2.0 %
          Related substances (HPLC, EP) (Sum of all impurities)≤ 3.0 %
          Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.8
          Reducing sugars (as glucose)≤ 0.11
          Sulfated ash≤ 0.02 %
          Water≤ 1.5 %
          Particle size (< 212 µm)≤ 10 %
          Particle size (> 850 µm)≤ 10 %
          Residual solvents (ICH Q3C)excluded by manufacturing process
          Microbiological testpasses test
          Colony count (aerobic bacteria (TAMC))≤ 5*10²
          Colony count (Yeasts and moulds (TYMC))≤ 10²
          Salmonella spp.In 10g substance not detectable
          E.coliIn 1g substance not detectable
          Staphylococcus aureusIn 1g substance not detectable
          Pseudomonas aeruginosaIn 1g substance not detectable
          Candida albicansIn 1g substance not detectable
          Loss on drying≤ 3.0
          Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
          Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified an indicated (#).
          Corresponds to Ph. Eur., BP, JSFA, NF, E 420
          Conforms to the purity criteria on food additives according to the current European Commission Regulation.

          Documentation

          Material Qualification Dossier

          Title

          Quality Management Dossier

          Title

          Operational Excellence Dossier

          Title

          Parteck® SI 400 (Sorbitol) SDS

          Title

          Safety Data Sheet (SDS) 

          Parteck® SI 400 (Sorbitol) Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1031409500 Big BagPDF Specification Document

          Certificates

          Title

          Brochure

          Title
          MultiPharmTM Minerals for Solid Dosage Forms